NCT01919632

Brief Summary

Background: The impact of demographic changes on workplace has increased the importance of effective occupational preventive health programs. The primary goal of these programs is the improvement of overall health status (and therefore increase productivity and decrease healthcare costs) of the increasingly older workforce through positive lifestyle behavior change. A one- year preventive health behavior-change program for the employees of the company British Petrol (BP) shall be scientifically evaluated. The initial stage of the program consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of supervised endurance exercise (i.e. jogging, nordic walking, cycling or swimming) in groups. In the second phase of the program, the participants receive a recommendation to continue exercise regularly unsupervised for one year, and receive monthly supervised exercise training sessions. Clinical check-ups are performed at baseline (V1) at three months (V2) and at 12 months (V3).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

3.6 years

First QC Date

July 5, 2013

Last Update Submit

May 11, 2015

Conditions

Keywords

lifestylephysical activityendothelial functioncardiovascularoccupationalprevention

Outcome Measures

Primary Outcomes (1)

  • Change in RHI (Reactive Hyperemia Index)

    endothelial function

    after 0 months (V1), 3 months (V2), 12 months (V3)

Secondary Outcomes (7)

  • Exercise capacity (Watt/kg)

    after 0 month (V1) and after 12 month (V3)

  • CAVI (Cardio ankle vascular index)

    after 0 months (V1), 3 months (V2), 12 months (V3)

  • Anthropometric parameters (see description)

    after 0 months (V1), 3 months (V2), 12 months (V3)

  • Inflammatory and metabolic parameters from blood samples (see description)

    after 0 month (V1), 3 month (V2), 12 month (V3)

  • Health related quality of life (HRQoL)

    after 0 month (V1) and 12 month (V3)

  • +2 more secondary outcomes

Study Arms (1)

Lifestyle

EXPERIMENTAL

The initial stage of the program consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of supervised endurance exercise (i.e. (?) jogging, nordic walking, cycling or swimming) in groups. In the second phase of the program, the participants receive a recommendation to continue exercise regularly unsupervised for one year, and receive monthly supervised exercise training sessions.

Behavioral: health-behavior seminar and endurance exercise

Interventions

The initial stage of the program consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of supervised endurance exercise (i.e. jogging, nordic walking, cycling or swimming) in groups. In the second phase of the program, the participants receive a recommendation to continue exercise regularly unsupervised for one year, and receive monthly supervised exercise training sessions.

Lifestyle

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Employees of the company British Petrol (BP) in Lingen, Germany
  • men and woman of all age
  • approval for being able to participate in physical activity
  • existing, written agreement to study-participation with prior, detailed education

You may not qualify if:

  • Acute or chronic disease of any kind, which does not allow participation in physical activity (missing approval of being able to participate in physical activity)
  • Incompetent patient, who is not able to understand character, meaning and consequences of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinikum rechts der Isar, Technische Universität München

Munich, Bavaria, 80992, Germany

Location

BP Lingen

Lingen, Emsland, 49808, Germany

Location

Related Publications (1)

  • Schaller N, Blume K, Hornig M, Senker L, Wolfarth B, Schuster T, Halle M, Esefeld K; MOVING (MOtiVation, INtervention and Vascular chanGe) study group. Occupational life-style programme over 12 months and changes of metabolic risk profile, vascular function, and physical fitness in blue-collar workers. J Occup Med Toxicol. 2023 Mar 22;18(1):4. doi: 10.1186/s12995-023-00370-w.

MeSH Terms

Conditions

HyperemiaMotor Activity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Martin Halle, Prof.

    Klinikum rechts der Isar, Department of Prevention and Sports medicine, Technische Universität München

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2013

First Posted

August 9, 2013

Study Start

October 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations